AstraZeneca recently released positive new data on its experimental non-small cell lung cancer (NSCLC) drug, AZD9291 (osimertinib)
AstraZeneca recently released positive new data on its experimental non-small cell lung cancer (NSCLC) drug, AZD9291 (osimertinib).
The data was presented at the World Conference on Lung Cancer (WCLC) 2015 September 6 to 9 in Denver, Colo. Two trials examined epidermal growth factor receptor mutation (EGFRm) positive advanced NSCLC patients and previously-treated patients with EGFR T790M mutation-positive NSCLC.
Data in the first-line setting demonstrated that 72% of patients who received AZD9291 once daily were progression-free (PFS) at 12 months. Confirmed overall response rate (ORR) was 75% and the longest duration of response (DoR) was ongoing at 18 months.
“While the data are still preliminary, these latest results from the AURA trial first-line cohort further reinforce the potential of AZD9291 in treatment-naïve EGFRm advanced NSCLC patients,” said Professor Suresh S. Ramalingam, presenting author of the AURA trial first-line cohort data and chief of thoracic oncology and director of medical oncology at Emory University School of Medicine in Atlanta.
Data on 2 AURA phase 2 studies (AURA extension and AURA2) in previously treated patients with EGFR T790M mutation were also presented. While still preliminary, these studies showed an efficacy and tolerability profile for AZD9291 consistent with previously reported data.
“The data support our accelerated development strategy with AZD9291, which has moved with unprecedented speed from first human studies to the U.S. Food and Drug Administration and other regulatory submissions,” said Antoine Yver, head of oncology and Global Medicines Development at AstraZeneca. “With AZD9291 now under review by global regulatory authorities, we are on track to bring this innovative medicine to patients as quickly as possible to address this critical need.”
FDA recently granted priority review to AZD9291, adding to the breakthrough therapy designation, orphan drug and fast-track status already assigned by the regulatory body.
Further trials of AZD9291 are also underway to investigate its potential for overcoming newly identified forms of resistance for a broader range of patients. They include a phase 3 study combining AZD9291 with durvalumab as a potential second-line treatment for patients with EGFR T790M mutation-positive locally advanced or metastatic NSCLC (CAURAL, NCT02454933) and the ongoing TATTON (NCT02143466) study, which is investigating the combination of AZD9291 with durvalumab, selumetinib, or savolitinib in patients with EGFRm advanced NSCLC who have progressed following therapy with an EGFR tyrosine kinase inhibitor (TKI).